Accuracy of Human Papillomavirus (HPV) Testing on Urine and Vaginal Self-Samples Compared to Clinician-Collected Cervical Sample in Women Referred to Colposcopy

In the context of cervical cancer prevention, where human papillomavirus (HPV) infection is pivotal, HPV testing is replacing Pap Smear in primary screening. This transition offers an opportunity for integrating self-sampling to enhance coverage. We evaluated the accuracy of HPV testing using self-collected urine and vaginal samples, comparing them to physician-collected cervical swabs. From a cohort of 245 women with abnormal cytology, we collected self-sampled vaginal, urine, and clinician-administered cervical specimens. Employing Anyplex™II HPV28 assay, outcomes revealed HPV positivity rates of 75.1% (cervical), 78.4% (vaginal), and 77.1% (urine). Significant, hr-HPV detection concordance was observed between self-taken cervical samples and clinical counterparts (k = 0.898 for vaginal; k = 0.715 for urine). This study extends beyond accuracy, highlighting self-collected sample efficacy in detecting high-grade cervical lesions. The insight underscores self-sampling’s role in bolstering participation and aligns with WHO’s goal to eliminate cervical cancer by 2030.

[1]  P. Castle,et al.  Offering HPV self-sampling kits: an updated meta-analysis of the effectiveness of strategies to increase participation in cervical cancer screening , 2022, British Journal of Cancer.

[2]  S. Weyers,et al.  Validation of BD Onclarity HPV assay on vaginal self-samples versus cervical samples using the VALHUDES protocol. , 2022, Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology.

[3]  S. Weyers,et al.  Analytical and clinical performance of extended HPV genotyping with BD Onclarity HPV Assay in home-collected first-void urine: A diagnostic test accuracy study. , 2022, Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology.

[4]  Jae Hyun Kim,et al.  Comparison of Seegene Anyplex II HPV28 assay with BD Onclarity HPV assay for human papillomavirus genotyping , 2022, PloS one.

[5]  M. Schiffman,et al.  Meta‐analysis of agreement/concordance statistics in studies comparing self‐ vs clinician‐collected samples for HPV testing in cervical cancer screening , 2022, International journal of cancer.

[6]  J. Doyen,et al.  Clinical and analytical evaluation of the RealTime High Risk HPV assay in Colli-Pee collected first-void urine using the VALHUDES protocol. , 2021, Gynecologic oncology.

[7]  M. Poljak,et al.  2020 List of human papillomavirus assays Suitable for primary cervical cancer screening. , 2021, Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases.

[8]  K. Jochumsen,et al.  Clinical performance and acceptability of self-collected vaginal and urine samples compared with clinician-taken cervical samples for HPV testing among women referred for colposcopy. A cross-sectional study , 2021, BMJ Open.

[9]  Maria Hortlund,et al.  Human papillomavirus genotype-specific risks for cervical intraepithelial lesions , 2020, Human vaccines & immunotherapeutics.

[10]  J. Dillner,et al.  How many Human Papillomavirus types do we need to screen for? , 2020, The Journal of infectious diseases.

[11]  Y. Woo,et al.  The Acceptability and Preference of Vaginal Self-sampling for Human Papillomavirus (HPV) Testing among a Multi-ethnic Asian Female Population , 2020, Cancer Prevention Research.

[12]  M. Poljak,et al.  Cervical screening: ESGO-EFC position paper of the European Society of Gynaecologic Oncology (ESGO) and the European Federation of Colposcopy (EFC) , 2020, British Journal of Cancer.

[13]  Y. Qiao,et al.  Comparison of the performance of paired urine and cervical samples for cervical cancer screening in screening population , 2020, Journal of medical virology.

[14]  F. Landoni,et al.  Prevalence of Human Papillomavirus (HPV) and Other Sexually Transmitted Infections (STIs) among Italian Women Referred for a Colposcopy , 2019, International journal of environmental research and public health.

[15]  J. Cuzick,et al.  Role of HPV Genotype, Multiple Infections, and Viral Load on the Risk of High-Grade Cervical Neoplasia , 2019, Cancer Epidemiology, Biomarkers & Prevention.

[16]  F. Landoni,et al.  Prevalence of Chlamydia trachomatis Infection, Serovar Distribution and Co-Infections with Seven High-Risk HPV Types among Italian Women with a Recent History of Abnormal Cervical Cytology , 2019, International journal of environmental research and public health.

[17]  J. Y. Park,et al.  Evaluation of satisfaction with three different cervical cancer screening modalities: clinician-collected Pap test vs. HPV test by self-sampling vs. HPV test by urine sampling , 2019, Journal of gynecologic oncology.

[18]  P. Romundstad,et al.  Clinical performance of Anyplex II HPV28 by human papillomavirus type and viral load in a referral population , 2019, PloS one.

[19]  S. Temin,et al.  Detecting cervical precancer and reaching underscreened women by using HPV testing on self samples: updated meta-analyses , 2018, British Medical Journal.

[20]  M. Poljak,et al.  VALHUDES: A protocol for validation of human papillomavirus assays and collection devices for HPV testing on self-samples and urine samples. , 2018, Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology.

[21]  P. van Damme,et al.  Human papillomavirus genotype and viral load agreement between paired first-void urine and clinician-collected cervical samples , 2018, European Journal of Clinical Microbiology & Infectious Diseases.

[22]  D. Geraets,et al.  Comparison of the analytical and clinical performance of five tests for the detection of human papillomavirus genital infection. , 2017, Journal of virological methods.

[23]  P. van Damme,et al.  First-void urine: A potential biomarker source for triage of high-risk human papillomavirus infected women. , 2017, European journal of obstetrics, gynecology, and reproductive biology.

[24]  S. Rosini,et al.  Analytic and Diagnostic Performances of Human Papillomavirus E6/E7 mRNA Test on up-to 11-Year-Old Liquid-Based Cervical Samples. A Biobank-Based Longitudinal Study , 2017, International journal of molecular sciences.

[25]  M. Poljak,et al.  VALGENT: A protocol for clinical validation of human papillomavirus assays. , 2016, Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology.

[26]  P. Hillemanns,et al.  Reaching women who do not participate in the regular cervical cancer screening programme by offering self-sampling kits: a systematic review and meta-analysis of randomised trials. , 2015, European journal of cancer.

[27]  P. van Damme,et al.  Urine testing for HPV: rationale for using first void , 2014, BMJ : British Medical Journal.

[28]  Y. Qiao,et al.  Comparison of HPV genotypes and viral load between different sites of genital tract: the significance for cervical cancer screening. , 2014, Cancer epidemiology.

[29]  J. Berkhof,et al.  Efficacy of HPV-based screening for prevention of invasive cervical cancer: follow-up of four European randomised controlled trials , 2014, The Lancet.

[30]  S. Kjaer,et al.  High-Risk and Low-Risk Human Papillomavirus and the Absolute Risk of Cervical Intraepithelial Neoplasia or Cancer , 2014, Obstetrics and gynecology.

[31]  M. Capobianchi,et al.  Comparison of the Abbott RealTime High Risk HPV with Genomica HPV Clinical Array for the detection of human papillomavirus DNA , 2013, APMIS : acta pathologica, microbiologica, et immunologica Scandinavica.

[32]  D. Withrow,et al.  Self-collected HPV Testing Improves Participation in Cervical Cancer Screening: A Systematic Review and Meta-analysis , 2013, Canadian Journal of Public Health.

[33]  Julian Peto,et al.  Evidence regarding human papillomavirus testing in secondary prevention of cervical cancer. , 2012, Vaccine.

[34]  M. G. Dona',et al.  Comparative evaluation of different DNA extraction methods for HPV genotyping by linear array and INNO‐LiPA , 2011, Journal of medical virology.

[35]  J. Cuzick,et al.  Guidelines for human papillomavirus DNA test requirements for primary cervical cancer screening in women 30 years and older , 2009, International journal of cancer.

[36]  J. R. Landis,et al.  The measurement of observer agreement for categorical data. , 1977, Biometrics.

[37]  W. Prendiville,et al.  Diagnostic accuracy of human papillomavirus testing in primary cervical screening: a systematic review and meta-analysis of non-randomized studies. , 2007, Gynecologic oncology.

[38]  Cdm Fletcher,et al.  World Health Organization Classification of Tumours , 2002 .